MAUDE Adverse Event Report: TECAN SYSTEMS INC BD FACS SAMPLE PREP ASSISTANT III (BD SPA III

Model Number 647205

Device Problems Break (1069); Fluid/Blood Leak (1250); Mechanical Jam (2983)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/10/2014

Event Type  Other  

Event Description

On (b)(6) 2014 a (b)(6) bd field service engineer (fse) at (b)(6), dept of haematology, (b)(6) was exposed to biohazard waste during a service visit.Reported to bd biosciences on (b)(6) 2014.The exit waste quick-connect on the fluidics tower of the bd facs spa iii was broken and the engineer's visit was to resolve the situation.The male part of the fitting was jammed in the female part.The engineer proceeded to replace the female quick-disconnect mounted in the fluidics tower.Decontamination of the system by the customer was not possible due to the failure mode.Upon cutting the tubing to the fluidic fitting, residual pressure in the waste tube sprayed biohazardous waste at the engineer's face.The engineer was immediately taken to the accident and emergency dept (er) for a hepatitis b injection and immediate hiv post-exposure prophylaxis (pep) and treatment continues.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT III (BD SPA III
• Type of Device: BD SPA III
• Manufacturer (Section D): TECAN SYSTEMS INC; 2450 zanker rd; san jose CA 95131
• Manufacturer Contact: eric claussen, dir, reg compl ; 2350 qume dr.; san jose, CA 95131 ; 4089546348
• MDR Report Key: 4006471
• MDR Text Key: 4709888
• Report Number: 2916837-2014-00001
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention